Donanemab: Difference between revisions

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| pregnancy = Limited data

| legal = Rx; ARIA monitoring required

| intro = '''Donanemab''' (brand name Kisunla) is a humanized monoclonal antibody targeting N-terminally truncated, pyroglutamated Aβ — an Aβ form found predominantly in established plaques. FDA-approved in July 2024 for Alzheimer disease (MCI/mild AD). Unique among approved anti-amyloid mAbs: patients can '''discontinue treatment once amyloid PET shows plaque clearance''', typically within 12-18 months. This stop-criterion (a finite course rather than indefinite biweekly infusions like lecanemab) is donanemab's main clinical advantage.

| intro = '''Donanemab''' (brand name Kisunla) is a humanized monoclonal antibody targeting N-terminally truncated, pyroglutamated Aβ, an Aβ form found predominantly in established plaques. FDA-approved in July 2024 for Alzheimer disease (MCI/mild AD). Unique among approved anti-amyloid mAbs: patients can '''discontinue treatment once amyloid PET shows plaque clearance''', typically within 12-18 months. This stop-criterion (a finite course rather than indefinite biweekly infusions like lecanemab) is donanemab's main clinical advantage.

Pivotal trial (TRAILBLAZER-ALZ 2): ~35% slowing of cognitive decline on integrated Alzheimer Disease Rating Scale (iADRS) over 18 months. The trial enriched for tau-positive patients. As with other anti-amyloid mAbs, ARIA is the principal safety concern, with higher rates than lecanemab (especially ARIA-E in ~25% of treated patients).

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[[Category:Anti-Dementia Medicines]]

~~[[Category:Anti-dementia]]~~

[[Category:Anti-Amyloid Monoclonal Antibodies]]

~~[[Category:Anti-Amyloid Antibodies]]~~

[[Category:Alzheimer Disease Medicines]]

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